NCT03111979

Brief Summary

The older population is the fastest growing age group worldwide, but it is also the most susceptible to chronic diseases and disabilities. One of the most common negative consequences of aging is the decline in muscle mass, strength and power. This is most notable in lower limb muscles. These muscles are required for the performance of daily activities including walking, stair climbing and standing up from sitting. Regular exercise is considered one of the most effective measures to slow, and even reverse the progression of muscle weakness. Nevertheless older adults may notice a decline in their capability to undertake regular exercises, this may be due to a decline in their muscle's ability to buffer pH. Carnosine (made by bonding β-alanine and histidine) has been suggested to contribute to the extension of physical performance, counteracting the decline the muscle's ability to buffer pH. Yet this pH buffering process it largely restricted by the amount of β-alanine available in the human body. β-alanine is already known to decline in older individuals due to a reduction in food products (meat, fish and poultry). Yet through either consumption of β-alanine rich food, or through short-term supplementation, β-alanine is raised, increasing carnosine concentrations. Improved β-alanine levels can potentially advance exercise performance, for example significant improvements in time to exhaustion on both a constant (37%) and incremental (12%) treadmill tests have been demonstrated. It is therefore proposed that via β-alanine supplementation, an individual's perception of their frailty, maintenance of health and independent living can be improved in older individuals. However, these findings are based on participants, both young and older, who are well-rested with no prior exercise or fatigue to the assessed muscles. It remains unclear if β-alanine supplementation will aid in the buffering of pH when the muscle has already been fatigued. Therefore this investigation hopes to examine the effects of 4 week β-alanine supplementation on lower limb contractile and force properties, pre and post muscle specific fatigue.

Trial Health

20
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_4

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

4 years

First QC Date

April 7, 2017

Last Update Submit

April 12, 2017

Conditions

Keywords

beta-alanineCarnosineNeuromuscularStimulationSkeletal muscle

Outcome Measures

Primary Outcomes (1)

  • Half relaxation time

    The time taken to decline to 50% maximum following a evoked twitch contraction

    4 weeks

Secondary Outcomes (5)

  • Force frequency relationship

    4 weeks

  • Time to peak tension

    4 weeks

  • Electromechanical delay

    4 weeks

  • Maximal voluntary force production

    4 weeks

  • Explosive voluntary force production

    4 weeks

Study Arms (2)

Beta-alanine supplementation

EXPERIMENTAL

Participants will be supplemented with 4.8g·d-1 β-alanine (CarnoSyn™, NAI, USA). The β-alanine dosing regimen will consist of two 800 mg tablets three times per day at 3-4 hour intervals or the same regimen for placebo tablets. The use of multiple small doses throughout the day has been used in numerous studies using β-alanine in solutions or gelatine capsules (Hoffman et al., 2008; Sale et al., 2011; Saunders et al., 2012; Sale et al., 2012; Tobias et al., 2013) in order to circumvent potential symptoms of paraesthesia (see box xii for possible risks and discomforts). Overall increases have been shown to be between 40% and 80% depending upon dose (between 3.2 and 6.4 g·d-1) and duration of administration (between 4 and 10 weeks) (Sale et al., 2012).

Dietary Supplement: beta-alanine

Placebo

PLACEBO COMPARATOR

Participants will be supplemented with 4.8 g·d-1 placebo (maltodextrin; NAI, USA). The regimen will consist of two 800 mg tablets three times per day at 3-4 hour intervals the same regimen for beta-alanine tablets

Dietary Supplement: Placebo

Interventions

beta-alanineDIETARY_SUPPLEMENT
Beta-alanine supplementation
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants will be defined as 'medically stable' for exercise studies, as proposed by Grieg et al. (1994). This criteria was designed both for safety and to define degrees of freedom from diseases which might alter exercise performance (Greig et al., 1994).

You may not qualify if:

  • Participants will be excluded if they are vegetarian/vegan or have been using β-alanine or creatine supplements within the past 6 months. They will also be excluded if they have participated in a resistance training programme in the last 6 months. These criteria will apply throughout the whole study, with any participants immediately excluded from the study if any of these medical conditions should arise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Sale C, Saunders B, Harris RC. Effect of beta-alanine supplementation on muscle carnosine concentrations and exercise performance. Amino Acids. 2010 Jul;39(2):321-33. doi: 10.1007/s00726-009-0443-4. Epub 2009 Dec 20.

  • Sale C, Artioli GG, Gualano B, Saunders B, Hobson RM, Harris RC. Carnosine: from exercise performance to health. Amino Acids. 2013 Jun;44(6):1477-91. doi: 10.1007/s00726-013-1476-2. Epub 2013 Mar 12.

  • Harris RC, Sale C. Beta-alanine supplementation in high-intensity exercise. Med Sport Sci. 2012;59:1-17. doi: 10.1159/000342372. Epub 2012 Oct 15.

  • Artioli GG, Gualano B, Smith A, Stout J, Lancha AH Jr. Role of beta-alanine supplementation on muscle carnosine and exercise performance. Med Sci Sports Exerc. 2010 Jun;42(6):1162-73. doi: 10.1249/MSS.0b013e3181c74e38.

MeSH Terms

Interventions

beta-Alanine

Intervention Hierarchy (Ancestors)

AlanineAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic Associate

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 13, 2017

Study Start

April 1, 2014

Primary Completion

April 1, 2018

Study Completion

October 1, 2018

Last Updated

April 13, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share